compassionate
Romanian translation: (acces) extins / compasional
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| 09:55 Apr 4, 2024 |
| English to Romanian translations [PRO] Medical - Medical (general) | |||||||
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|  Selected response from: Éva Krecht Romania Local time: 09:31 | ||||||
Grading comment
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| Summary of answers provided | ||||
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| 4 +2 | (acces) extins / compasional |
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| 5 | de urgență/în circumstanțe excepționale |
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| Summary of reference entries provided | |||
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| compassionate use |
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Answers
52 mins confidence: 
de urgență/în circumstanțe excepționale Explanation: https://hallo.ro/dictionar-englez-roman/compassionate#google... |
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Notes to answerer
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3 hrs confidence: 
peer agreement (net): +2
peer agreement (net): +2(acces) extins / compasional Explanation: „Contrary to common usage, the terms “emergency use” and “compassionate use” are not synonymous. Become aware of the specific, separate standards for emergency use and compassionate use/expanded use to avoid violating federal regulations and UCSF policy regarding the use of unapproved drugs, biologics and devices. Different FDA regulations apply to the different types of test article use, and the terminology can be confusing. Use the following definitions: (...) Emergency use Use of an investigational drug, biological product, or medical device generally requires either an IND (for unapproved drugs and biologics) or an IDE (for unapproved devices). (...) Expanded access Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product. A patient may be able to receive the product (when appropriate) through expanded access when enrollment in a clinical trial is not possible, e.g., a patient is not eligible for any ongoing clinical trials, or there are no ongoing clinical trials.” https://irb.ucsf.edu/emergency-use-and-compassionate-use-exp... „An unlicensed medicine is not available on the market and it can only be used in clinical studies or in a compassionate use/expanded access setting.” https://toolbox.eupati.eu/resources/off-label-use/ „Compassionate Use Method of providing an unlicensed medicine prior to final approval by a regulatory (competent) authority for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained for compassionate use of a medicine or therapy.” https://toolbox.eupati.eu/glossary/compassionate-use/ „Un medicament neautorizat nu este disponibil pe piață și poate fi utilizat numai în studii clinice sau în situații de uz compasional/acces extins.” https://toolbox.eupati.eu/resources/utilizarea-in-alte-modur... „Uz compasional Metodă de furnizare a unui medicament neaprobat, înainte de autorizarea finală a acestuia de către o autoritate (competentă) de reglementare a medicamentelor de uz uman. Această procedură este utilizată în cazul persoanelor foarte bolnave, care nu au alte opțiuni de tratament. În numeroase circumstanțe, este necesară obținerea unei aprobări separate pentru fiecare caz de uz compasional al unui medicament sau al unei terapii.Ć https://toolbox.eupati.eu/glossary/uz-compasional/?lang=ro „Acest program este conceput pentru a oferi acces compasional la cannabis în scopuri medicale acolo unde tratamentele convenționale au eșuat,” https://ro.formulaswiss.com/blogs/știri-din-industrie/pasul-... Uzul compasional – sau utilizarea compasională – înseamnă permisiunea acordată de autoritățile de reglementare în cazul unui medicament neautorizat (experimental) la un grup extins de pacienți care nu au opțiuni de tratament ...” https://www.monitorulbt.ro/localbt/2020/05/24/moartea-asiste... https://ro.wikipedia.org/wiki/Uz_compasional |
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Grading comment
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Notes to answerer
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21 hrs |
| Reference: compassionate use Reference information: https://eur-lex.europa.eu/legal-content/EN-RO/TXT/?from=EN&u... folosire în tratamente de ultima instanță |
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Note to reference poster
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